In a single-center phase II trial reported in the Journal of Clinical Oncology, Renata Ferrarotto, MD, and colleagues found that the combination of axitinib and avelumab showed evidence of activity in patients with recurrent or metastatic adenoid cystic carcinoma.

Study Details

In the study, 28 evaluable patients with disease progression within the prior 6 months were enrolled at The University of Texas MD Anderson Cancer Center between July 2019 and June 2021. Patients received axitinib at 5 mg twice a day and avelumab at 10 mg/kg on days 1 and 15 of 28-day cycles.

A total of 36% of patients had received at least one prior line of treatment. The primary endpoint was objective response rate, with the null hypothesis rejected if four or more responses were observed among the first 29 patients treated. 

Renata Ferrarotto, MD

Responses

Objective responses (all partial) were observed in six patients (21%, 95% confidence interval [CI] = 8.3%–41%). One response was unconfirmed, due to early disease progression in nontarget lesions, resulting in a confirmed objective response rate of 18% (95% CI = 6.1%–36.9%). Of the six responses, two occurred after 6 months, resulting in an objective response rate at 6 months of 14% (95% CI = 4.0%–32.7%). An additional 14 patients (50%) had stable disease, yielding a disease control rate of 71%. Median durations of response were 5.5 months (95% CI = 3.7 months to not reached) among the six responders and 11 months (95% CI = 5.5 months to not reached) among the five patients with a confirmed response.

Median follow-up for surviving patients was 22 months (95% CI = 16.6–39.1 months). Median progression-free survival was 7.3 months (95% CI = 3.7–11.2 months), with a 6-month rate of 57% (95% CI = 41%–78%). Median overall survival was 16.6 months (95% CI = 12.4 months to not reached), with a 6-month rate of 86% (95% CI = 73.7%–99.7%).

Adverse Events

Among 34 patients included in the safety analysis, the most common treatment-related adverse events of any grade were fatigue (62%), hypertension (32%), and diarrhea (32%). Grade 3 treatment-related adverse events occurred in 29% of patients, most commonly hypertension (9%), fatigue (6%), deep vein thrombosis (6%), and palmar-plantar erythrodysesthesia (6%); no grade 4 or 5 events were observed. Adverse events led to discontinuation of avelumab in 12% of patients.

The investigators concluded, “The study reached its primary endpoint with four or more partial responses in 28 evaluable patients (confirmed objective response rate of 18%). The potential added benefit of avelumab to axitinib in adenoid cystic carcinoma requires further investigation.”

Dr. Ferrarotto, of the Department of Thoracic/Head & Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Pfizer, as part of an alliance between Pfizer and the health-care business of Merck KGaA, and by a grant from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.